MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. GUARDUS OVERTUBE - GASTRIC

Model Number	00711148
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The disposable overtube is a device used in conjunction with a flexible endoscope for foreign body or tissue retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations.The report indicates that the tip of the overtube detached during a procedure.The detachment was noted after the procedure was completed and the detached component was retrieved.The device history record was reviewed and confirmed the devices were manufactured to specification.There have been no other complaints associated with this lot.The device subject of this complaint was not returned to us endoscopy for evaluation.The instructions for use include the following statements: "inspect the package for shipping or handling damage (i.E.Deformed tubes, holes in packaging).If damage is evident, do not use this device.Generously lubricate both components with a water soluble lubricant as described below in the directions for use.Do not assemble without generous lubrication." the distributor has provided in-service training to the facility.There have been no further reported issues since in-service was completed.
Event or Problem Description
The distributor in (b)(4) reported the tip detached from a guardus overtube during procedural use.The detached portion was retrieved, and the procedure was completed.There was no report of patient or user harm as a result of the component detachment nor retrieval.

• Brand Name: GUARDUS OVERTUBE - GASTRIC
• Common Device Name: OVERTUBE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 7852897
• Report Number: 1528319-2018-00030
• Device Sequence Number: 1966397
• Product Code: FED
• UDI-Device Identifier: 00816765011225
• UDI-Public: (01)00816765011225
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K040836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/21/2020
• Device Model Number: 00711148
• Device Catalogue Number: 00711148
• Device Lot Number: 1706716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1